Frailty, Immunonutrition, Surgery Type, and Biologic Recovery in Elderly Gastric Cancer
September 2, 2026 updated by: Adem Yüksel, Kocaeli City Hospital
The Effects of Multidimensional Frailty Phenotypes, Immunonutritional Status, and Surgical Approach on Biological Recovery in Elderly Patients Undergoing Gastric Cancer Surgery: A Prospective Observational Study
This prospective observational cohort study will evaluate the effects of multidimensional frailty phenotypes, immunonutritional status, and surgical approach on biological recovery in patients aged 60 years and older undergoing surgery for gastric cancer.
Preoperative assessment will include physical and cognitive frailty, nutritional status, handgrip strength, and skeletal muscle characteristics on computed tomography.
Patients will be followed prospectively during the perioperative period, including assessment of inflammatory markers, postoperative complications, delirium, hospital length of stay, and functional recovery.
The study aims to determine whether multidimensional frailty and immunonutritional factors are associated with postoperative outcomes and whether surgical approach influences biological recovery in older patients with gastric cancer.
A total of 328 patients are planned to be included at Kocaeli City Hospital.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This prospective, observational, analytical cohort study will be conducted at the General Surgery Clinic of Kocaeli City Hospital. The study will include patients aged 60 years and older who have gastric cancer and are scheduled for elective radical gastrectomy. A total of 328 patients are planned to be enrolled.
Preoperative assessment will include multidimensional frailty-related parameters, including the modified Frailty Index-11 (mFI-11), Montreal Cognitive Assessment (MoCA), handgrip strength, Nutritional Risk Screening 2002 (NRS-2002), Prognostic Nutritional Index (PNI), and skeletal muscle characteristics assessed on computed tomography at the L3 level. Baseline neutrophil-to-lymphocyte ratio (NLR) and C-reactive protein (CRP) levels will also be recorded.
Intraoperative data will include surgical approach, operative duration, and intraoperative blood loss. Postoperatively, NLR and CRP will be assessed on postoperative days 1, 3, and 5. Delirium will be evaluated using the Confusion Assessment Method (CAM). Postoperative complications will be recorded according to the Clavien-Dindo classification, together with hospital length of stay and handgrip strength before discharge.
The primary purpose of the study is to evaluate the association between multidimensional frailty phenotypes and postoperative outcomes and biological recovery in older patients undergoing gastric cancer surgery. The study will also investigate whether the surgical approach is associated with differences in biological recovery among patients with different frailty profiles.
Study Type
Observational
Enrollment (Estimated)
328
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Adem Yuksel, Assoc.Prof.
- Phone Number: 5053455259
- Email: drademyuksel@gmail.com
Study Contact Backup
- Name: Sumru Atak, M.D.
- Phone Number: 5546664272
- Email: berilsumru@gmail.com
Study Locations
-
-
İZMİT
-
Kocaeli, İZMİT, Turkey (Türkiye)
- Kocaeli City Hospital
-
Contact:
- Adem Yuksel, Assoc.Prof.
- Phone Number: +90 505 345 52 59
- Email: drademyuksel@gmail.com
-
Principal Investigator:
- Adem Yuksel, Assoc.Prof.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population will consist of patients aged 60 years and older with gastric cancer who are scheduled for elective radical gastrectomy at the General Surgery Clinic of Kocaeli City Hospital.
Eligible participants will be enrolled prospectively according to the predefined inclusion and exclusion criteria.
A total of 328 participants are planned to be included.
Description
Inclusion Criteria:
- Age 60 years or older.
- Histopathological or endoscopic diagnosis of gastric cancer.
- Planned elective radical gastrectomy.
- Written informed consent to participate in the study.
Exclusion Criteria:
- Stage IV metastatic gastric cancer.
- Requirement for emergency surgery.
- Severe neurological or psychiatric disease preventing completion of cognitive testing.
- Incomplete clinical data.
- Refusal to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Laparoscopic Surgery
Patients undergoing elective radical gastrectomy through a laparoscopic approach.
The surgical approach is determined by routine clinical practice and is not assigned by the study.
|
Elective radical gastrectomy performed using a laparoscopic approach as part of routine clinical care.
The surgical approach is not assigned by the study
|
|
Open Surgery
Patients undergoing elective radical gastrectomy through an open approach.
The surgical approach is determined by routine clinical practice and is not assigned by the study.
|
Elective radical gastrectomy performed using an open approach as part of routine clinical care.
The surgical approach is not assigned by the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of postoperative complication
Time Frame: Up to 30 days post-operative
|
According to the Clavien-Dindo classification, the status of postoperative complications during index hospitalisation.
|
Up to 30 days post-operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of Changes in the Neutrophil-to-Lymphocyte Ratio (NLR)
Time Frame: Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
|
Change in neutrophil-to-lymphocyte ratio from preoperative baseline to postoperative days 1, 3, and 5
|
Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in C-reactive protein (CRP) levels during the postoperative period compared with baseline values
Time Frame: Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
|
Change in C-reactive protein from preoperative baseline to postoperative days 1, 3, and 5.
|
Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
|
|
Rate of postoperative delirium
Time Frame: Day 1 post-operative, day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative.
|
Occurrence of postoperative delirium assessed daily using the Confusion Assessment Method.
|
Day 1 post-operative, day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative.
|
|
Comparison of length of stay in hospital
Time Frame: From date of surgery until date of hospital discharge, assessed up to 3 months
|
Hospital length of stay measured in days from surgery to hospital discharge.
|
From date of surgery until date of hospital discharge, assessed up to 3 months
|
|
Comparison of changes in hand grip strength
Time Frame: Baseline, pre-discharge
|
Change in handgrip strength from the preoperative assessment to the pre-discharge assessment
|
Baseline, pre-discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adem Yuksel, Assoc.Prof., Kocaeli City Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Partridge JS, Harari D, Martin FC, Dhesi JK. The impact of pre-operative comprehensive geriatric assessment on postoperative outcomes in older patients undergoing scheduled surgery: a systematic review. Anaesthesia. 2014 Jan;69 Suppl 1:8-16. doi: 10.1111/anae.12494.
- McIsaac DI, Taljaard M, Bryson GL, Beaule PE, Gagne S, Hamilton G, Hladkowicz E, Huang A, Joanisse JA, Lavallee LT, MacDonald D, Moloo H, Thavorn K, van Walraven C, Yang H, Forster AJ. Frailty as a Predictor of Death or New Disability After Surgery: A Prospective Cohort Study. Ann Surg. 2020 Feb;271(2):283-289. doi: 10.1097/SLA.0000000000002967.
- Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Japanese Gastric Cancer Association. Gastric cancer treatment guidelines 2021. Gastric Cancer. 2022;25:1-21.
- Ethun CG, Bilen MA, Jani AB, et al. Frailty and cancer surgery outcomes. Ann Surg Oncol. 2017;24:2131-2139.
- Shimada H, Makizako H, Lee S, Doi T, Lee S, Tsutsumimoto K, Harada K, Hotta R, Bae S, Nakakubo S, Harada K, Suzuki T. Impact of Cognitive Frailty on Daily Activities in Older Persons. J Nutr Health Aging. 2016;20(7):729-35. doi: 10.1007/s12603-016-0685-2.
- Jia G, Li K. Prognostic Nutritional Index is A Useful Predictive Marker for Morbidity and Mortality in Surgery for Perforated Peptic Ulcer. J Inflamm Res. 2025 Aug 14;18:11021-11028. doi: 10.2147/JIR.S519037. eCollection 2025.
- Kanasaki H, Oride A, Miyazaki K. Laparoscopic surgery in elderly patients aged 65 years and older with gynecologic disease. ISRN Obstet Gynecol. 2012;2012:678201. doi: 10.5402/2012/678201. Epub 2012 Nov 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Study Registration Dates
First Submitted
August 25, 2026
First Submitted That Met QC Criteria
September 2, 2026
First Posted (Actual)
September 3, 2026
Study Record Updates
Last Update Posted (Actual)
September 3, 2026
Last Update Submitted That Met QC Criteria
September 2, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-194 (Medical Ethics Committee of Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share individual participant data with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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